(270 days)
The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.
The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.
The provided text describes the 510(k) premarket notification for the YP-3000 Infant Incubator, demonstrating its substantial equivalence to a predicate device (OHMEDA MEDICAL OmniBed). This document focuses on proving equivalence through bench testing against recognized standards rather than detailing a clinical study with human readers or AI performance.
Therefore, many of the requested criteria for reporting an acceptance criteria and study proving performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or not specified in this regulatory submission, as it is for a physical medical device (infant incubator/warmer) and not an AI/ML powered diagnostic device.
However, I can extract information related to the acceptance criteria for the device's technical specifications and how its performance was proven through non-clinical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comprehensive comparison table between the subject device (YP-3000 Infant Incubator) and the predicate device (OmniBed), detailing various specifications and performance characteristics. The acceptance criteria essentially align with meeting the performance characteristics of the predicate device or demonstrating that any differences do not raise new questions of safety and effectiveness, often by showing compliance with relevant IEC and ISO standards.
| Acceptance Criteria (Corresponding Predicate Value or Standard) | Reported Device Performance (YP-3000) | Discussion of Equivalence and How Proven |
|---|---|---|
| Electrical Description | ||
| Power supply: 100V, 115V, 220V, 230V, 240V, 50/60Hz (Predicate) | AC 220-230V/50Hz; AC 110-120V/60Hz | Similar: Safety and performance tests based on IEC 60601-1, IEC 60601-2-19, and IEC 60601-2-21 cover both voltage ranges. Test results demonstrate compliance, raising no new safety/effectiveness questions. |
| Maximum current/power consumption: ≈1100VA (Predicate) | 1300VA | Similar: Safety and performance tests based on IEC 60601-1 conducted. Test results demonstrate compliance, raising no new safety/effectiveness questions. |
| Electrical safety: According to IEC 60601-1 (Predicate) | According to IEC 60601-1 | Same |
| Principles of Operation | ||
| General: Radiant Warmer and Infant Incubator (Predicate) | Radiant Warmer and Infant Incubator | Same |
| Control Modes: Incubator mode; Warmer mode (Predicate) | Incubator mode; Warmer mode | Same |
| Probe Type & Connectors: Air temp, Skin temp, air flow temp, O2, Humidity, Isolated air temp, Multi-port, RS232 (Predicate) | Air temp, Skin temp, air flow temp, O2, Humidity, Isolated air temp, Multi-port, RS232 | Same |
| Warmer Operation | ||
| Warmer: Radiant Warmer (Predicate) | Radiant Warmer | Same |
| Temperature Control Modes: Manual mode; Baby mode; (Pre-warm mode) (Predicate) | Pre-warm mode; Manual mode; Baby mode (Baby temperature control) | Same |
| Temperature Control Range Under Skin temp. Mode: 35~37.5°C in 0.1 increments (Predicate) | 34.5°C~37.5°C in 0.1 increments | Similar: Slightly wider range. Accuracy and consistency equivalent. Satisfies IEC60601-2-21 (201.15.4.2.2.101). No new safety/effectiveness questions. |
| Difference Between Skin Temperature Sensor and Control Temperature: ≤0.5°C (Predicate) | ≤0.5°C | Same |
| Temperature Uniformity of Bed Surface: ≤2°C (Predicate) | ≤2°C | Same |
| Incubator Operation | ||
| Heater: Convective heater (Predicate) | Convective heater | Same |
| Modes under the incubator mode: Air mode; Baby mode (Predicate) | Air mode; Baby mode | Same |
| Air Temperature Control range: 20~39℃ in 0.1 increments (Predicate) | 25~39℃ in 0.1 increments | Similar: Neonatal ambient temperature not less than 25℃, so YP-3000 range is designed accordingly. Accuracy and stability equivalent. Satisfies IEC60601-2-19 (201.15.4.2.2.101). No new safety/effectiveness questions. |
| Skin Temperature Control range: 35~37.5℃ in 0.1 increments (Predicate) | 34~38℃ in 0.1 increments | Similar: Slightly wider range. Accuracy and stability equivalent. Satisfies IEC60601-2-19 (201.15.4.2.2.102). No new safety/effectiveness questions. |
| Temperature Rise Time: <50min (Predicate) | ≤40min | Similar: Faster rise time. Product can be warmed to predetermined temperature. Meets IEC60601-2-19 (201.12.1.107). No new safety/effectiveness questions. |
| Difference Between Average Incubator Temperature and Control Temperature: ≤1.0°C (Predicate) | ≤1.0°C | Same |
| Difference Between Incubator Temperature and Average Incubator Temperature: ≤0.5°C (Predicate) | ≤0.5°C | Same |
| Skin Temperature Sensor Precision: ±0.3°C (Predicate) | ±0.2°C | Similar: More accurate. Satisfies IEC60601-2-19 (201.12.1.103). No new safety/effectiveness questions. |
| Humidity Control: 30% - 95% in 5% increments (Predicate) | 30% - 90% in 1% increments | Similar: YP-3000 range is included in predicate's range. No new safety/effectiveness questions. |
| Humidity Control Precision: ±10% for settings up to 85%; minimum 75% for settings >85% (Predicate) | ±5% RH | Similar: Better precision for YP-3000. No new safety/effectiveness questions. |
| Oxygen Concentration Control Range: 21% O₂~65% O₂ (Predicate) | 20% O₂~60% O₂ | Similar: YP-3000 range is included in predicate's range and verified to meet design requirement. No new safety/effectiveness questions. |
| Oxygen Concentration Control Precision: ±5% O₂ (Predicate) | ±4% O₂ | Similar: Slightly different but verified to meet design requirement. No new safety/effectiveness questions. |
| Carbon dioxide (CO2) Concentration Inside the Hood Under Incubator Mode: 0.2% (Predicate) | <0.5% | Similar: Both conform to IEC 60601-2-19 clause 201.12.4.2.101. No new safety/effectiveness questions. |
| Weight Scale | ||
| Function Range: 300mg to 8kg (Predicate) | 100mg to 8kg | Similar: Both comply with IEC 60601-2-19 (201.12.1.112). Difference does not affect temperature control performance as it's an auxiliary function. No new safety/effectiveness questions. |
| Accuracy: ± 10 mg (Predicate) | ± 10 mg | Same |
| Integrated X-Ray Cassette / Tray: Yes (Predicate) | Yes | Same |
| Drawer: Yes (Predicate) | Yes | Same |
| Bed-tilt Mechanism: Yes (Predicate) | Yes | Same |
| Operating Noise | ||
| Operating Noise Volume in Patient Compartment: <49dB (Predicate) | ≤50dB (Under the steady temperature condition) | Similar: Both meet IEC60601-2-19 clause 201.9.6.2.1.101. No new safety/effectiveness questions. |
| Alarm Volume: According to IEC 60601-2-19 and IEC 60601-1-8 (Predicate) | According to IEC 60601-2-19 and IEC 60601-1-8 | Same |
| Alarms | ||
| Power Failure Alarm: Yes (Predicate) | Yes | Same |
| Non-recoverable system failure: Yes (Predicate) | Yes | Same |
| Failure of Fan system: Fan Failure Alarm (Predicate) | Fan Motor Alarm | Same (functionally) |
| High Air Temp: 1.5°C over SET (Predicate) | Display temperature is 3°C higher than set temperature | Similar: Both meet IEC 60601-2-19 (201.15.4.2.1 dd). No new safety/effectiveness questions. |
| Low Air Temp: 3.0°C under SET (Predicate) | Display temperature is 3°C lower than set temperature | Same (functionally, 3.0°C vs 3°C) |
| Baby Cold: 1.0°C under SET (Predicate) | Display temperature of sensor 1 is 1°C lower than set temperature | Same |
| Baby Hot: 1.0°C over SET (Predicate) | Display temperature of sensor 1 is 1°C higher than set temperature | Same |
| Air Overheat: >38°C (SET≤37°C), >40°C (SET>37°C) (Predicate) | Temperature of incubator is not over 38°C (set value is less than 37°C), or not over 39.5°C (set value is over than 37°C) | Similar: Both meet IEC 60601-2-19 (201.15.4.2.1 aa). No new safety/effectiveness questions. |
| Skin Overheat Alarm: Not provided (Predicate) | The temperature measured by skin temperature sensor under the warmer mode is over 38.5°C | Similar: Both meet IEC 60601-2-19 (201.15.4.2.1 bb). No new safety/effectiveness questions. |
| Water Shortage: Water tank is lacking water (Predicate) | Water tank is lacking water | Same |
| Operating Condition Description | ||
| Temperature: +20~+30°C (Predicate) | +20~+30°C | Same |
| Humidity: 10% to 95% RH (Predicate) | 30%~75%RH | Similar: Environmental test report proves YP-3000 works normally under this condition. No new safety/effectiveness questions. |
| Storage Condition Description | ||
| Temperature: -25~+60°C (Predicate) | -20~+55°C | Similar: Environmental testing supports performance as intended. No new safety/effectiveness questions. |
| Relative humidity: ≤95%RH (Predicate) | ≤93%RH | Similar: Environmental testing supports performance as intended. No new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is a physical medical device. Performance claimed is based on laboratory bench testing against recognized standards, not on a data set of patient cases.
- Data Provenance: Not applicable. The "data" here refers to the outcomes of physical device measurements and assessments in a laboratory setting. No geographical or retrospective/prospective data collection is relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical device's performance (e.g., temperature accuracy, noise levels) is established through standardized engineering and safety tests, not through expert human interpretation of medical data (like in AI diagnostics). The "experts" involve engineers and technicians conducting the tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human or AI interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This is a medical device for infant care, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm. Bench testing demonstrates its standalone performance (i.e., the device itself performs according to specifications).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" for this device's performance is derived from measurements taken during rigorous bench testing against established international performance and safety standards (e.g., IEC 60601 series, ISO 10993 series). These standards define acceptable ranges for various parameters (temperature control, humidity, noise, alarms, electrical safety, biocompatibility, etc.). The device's measurements serve as its performance, and these are compared against the required thresholds and the predicate device's performance.
8. The sample size for the training set:
- Not applicable. This device does not use a training set as it is not an AI/ML system.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this physical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 25, 2019
Ningbo David Medical Device Co., Ltd Lin Dingyu Vice General Manager No.2, Keyuan Road, Shipu Technology Park, Xiangshan Ningbo. 15731 China
Re: K190494
Trade/Device Name: Infant Incubator Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal incubator Regulatory Class: Class II Product Code: FMZ, FMZ, FMT Dated: October 23, 2019 Received: October 25, 2019
Dear Lin Dingyu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190494
Device Name YP-3000 Infant Incubator
Indications for Use (Describe)
The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K190494 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
November 22, 2019
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | Ningbo David Medical Device Co., Ltd. |
|---|---|
| Company Address: | NO. 2, KEYUAN ROAD, SHIPU TECHNOLOGY PARK, XIANGSHAN, NINGBO, ZHEJIANG PROVINCE, P.R. China |
| Fax: | +86-574-87800008 |
Fax:
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | |
|---|---|
| Models: | |
| Product Codes: | |
| Regulation Number: | |
| Regulation Name: | |
| Device Class: |
Infant Incubator YP-3000 FMZ, FMT 21 CFR 880.5400 Neonatal incubator Class II
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of the predicate device within this submission is as follows:
Manufacturer: Trade Name: Product Codes: Regulation Name: Regulation Number: FDA 510 (k) #:
OHMEDA MEDICAL. OmniBed FMZ, FMT Neonatal incubator 21 CFR 880.5400 K993407
5. Description of the Device [21 CFR 807.92(a)(4)]
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The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.
6. Indications for Use [21 CFR 807.92(a)(5)]
The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.
7. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
| YP-3000Infant Incubator | OmniBed | Differences Discussion | |
|---|---|---|---|
| State | Subject Device | Predicate Device | N/A |
| Standards | IEC 60601-1IEC 60601-1-2IEC 60601-2-19IEC 60601-2-21ISO 10993-5ISO 10993-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-19IEC 60601-2-21ISO 10993-5ISO 10993-10 | Same |
| Indications forUse | The device is an infantincubator and aninfant warmer. Thetwo functions can beconverted through thecanopy lifting system.The incubatorprovides an enclosed,temperature-controlledenvironment and thewarmer providesinfrared heat in anopen environment.The warmer providesheat in a controlledmanner to neonateswho are unable tothermoregulate basedon their ownphysiology. Theincubator and warmermay also be used forshort periods of timeto facilitate aneonate's transitionfrom the uterus to theexternal environment. | The OmniBed is acombination of aninfant incubator(incubator) and aninfant warmer(warmer). Incubatorsand warmers provideheat in a controlledmanner to neonateswho are unable tothermo-regulatebased on their ownphysiology. Incubatorsprovide an enclosed,temperature-controlledenvironment andwarmers provideinfrared heat in anopen environment.They may also beused for short periodsof time to facilitate theneonate's transitionfrom the uterus to theexternal environment. | Similar - same intendeduse, users, and useenvironment; minorgrammatical differencesand device trade name isnot mentioned. |
| Electrical Description | |||
| Power supply | AC 220-230V/50Hz;AC 110-120V/60Hz | 100V, 115V, 220V,230V, 240V, 50/60Hz | Similar-1.We performed safety testsand performance testsbased on IEC 60601-1,IEC 60601-2-19 and IEC |
| 60601-2-21 standards tocover both voltage ranges.The test resultsdemonstrate that thesubject device YP-3000met the standardrequirements, so thisdifference does not raisenew questions of safetyand effectiveness. | |||
| Maximumcurrent/ powerconsumption | 1300VA | ≈1100VA | Similar-2.We conducted safety testsand performance testsbased on the IEC 60601-1standard. The test resultsdemonstrate that thesubject device YP-3000met the standardrequirements, so thisdifference does not raisenew questions of safetyand effectiveness. |
| Electrical safety | According to IEC60601-1 | According to IEC60601-1 | Same |
| Principles of Operation | |||
| General | Radiant Warmer andInfant Incubator | Radiant Warmer andInfant Incubator | Same |
| Control Modes | Incubator mode;Warmer mode | Incubator mode;Warmer mode | Same |
| Probe Type &Connectors | Air temperaturesensor | Air temperaturesensor | Same |
| Skin temperaturesensor | Skin temperaturesensor | Same | |
| air flow temp. sensor | air flow temp. sensor | Same | |
| O2 Sensors | O2 Sensors | Same | |
| Humidity Sensor | Humidity Sensor | Same | |
| Isolated airtemperature sensor | Isolated airtemperature sensor | Same | |
| Multi-port connectorconnects 2 | Multi-port connectorconnects 2 | Same | |
| transducers | transducers | ||
| RS232 connector | RS232 connector | Same | |
| Warmer Operation | |||
| Warmer | Radiant Warmer | Radiant Warmer | Same |
| TemperatureControl Modes | Pre-warm mode;Manual mode;Baby mode (Babytemperaturecontrol) | Manual mode;Baby mode;(Pre-warm mode); | Same |
| TemperatureControl RangeUnder the Skintemp. Mode | 34.5°C~37.5°C in 0.1increments | 35~37.5°C in 0.1increments | Similar-3.Compared with thepredicate device, thetemperature control rangeof the subject device YP-3000 is slightly wider, andunder this temperaturecontrol range, thetemperature controlaccuracy of the device, theconsistency of the bedtemperature and thepredicate device areequivalent. This controlrange satisfies therequirements of201.15.4.2.2.101 ofIEC60601-2-21. Thisdifference does not raisenew questions of safetyand effectiveness. |
| DifferenceBetween SkinTemperatureSensor andControlTemperature | ≤0.5°C | ≤0.5°C | Same |
| TemperatureUniformity ofBed Surface | ≤2°C | ≤2°C | Same |
| Incubator Operation | |||
| Heater | Convective heater | Convective heater | Same |
| Modes under theincubator mode | Air mode;Baby mode | Air mode;Baby mode | Same |
| Air TemperatureControl range | 25~39℃ in0.1increments | 20~39℃ in 0.1increments | Similar-4.Neonatal patients in theambient temperatureshould not be less than 25℃, so YP-3000 product aircontrol temperature rangeis designed to 25℃~39℃.Under this temperaturecontrol range, thetemperature controlaccuracy, temperaturestability and predicateequipment of theequipment are equivalent.This control range satisfiesthe requirements of201.15.4.2.2.101 inIEC60601-2-19. Therefore,this difference does notraise new questions ofsafety and effectiveness. |
| SkinTemperatureControl range | 34~38℃ in 0.1increments | 35~37.5℃ in 0.1increments | Similar-5.The comparison with thepredicate device, YP-3000's temperature controlrange is slightly wider, andunder this temperaturecontrol range, thetemperature controlaccuracy, temperaturestability and predicateequipment of the deviceare all equivalent. Thiscontrol range satisfies therequirements of201.15.4.2.2.102 in |
| IEC60601-2-19. Therefore,this difference does notraise new questions ofsafety and effectiveness. | |||
| TemperatureRise Time | ≤40min | <50min | Similar-6.Compared with thepredicate device, thetemperature rise time ofthe YP-3000 is faster, andthe product can bewarmed up to thepredeterminedtemperature and put intouse. The performance ofthis article meets therequirements of201.12.1.107 in IEC60601-2-19, so this differencedoes not raise newquestions of safety andeffectiveness. |
| DifferenceBetweenAverageIncubatorTemperatureand ControlTemperature | ≤1.0°C | ≤1.0°C | Same |
| DifferenceBetweenIncubatorTemperatureand AverageIncubatorTemperature | ≤0.5°C | ≤0.5°C | Same |
| SkinTemperatureSensor Precision | ±0.2°C | ±0.3°C | Similar-7.Compared with thepredicate device, the skintemperature display of YP-3000 is more accurate.The performance of thisarticle satisfies therequirements of201.12.1.103 in IEC60601- |
| 2-19, so this differencedoes not raise newquestions of safety andeffectiveness. | |||
| Humidity Control | 30% - 90% in 1%increments | 30% - 95% in 5%increments | Similar-8.Compared with thepredicate device, thehumidity control range ofthe YP-3000 is included inthe humidity control rangeof the predicate device, sothis difference does notraise new questions ofsafety and effectiveness. |
| Humidity ControlPrecision | ±5% RH | ±10% for settings upto 85%; minimum 75%for settings >85% | Similar-9.Based on the analysis ofthe humidity control range,this indicator indicates thedeviation range betweenthe actual humidity and thecontrol value in theincubator during humiditycontrol, the humiditycontrol precision of subjectdevice YP-3000 is betterthan the predicate device,so this difference does notraise new questions ofsafety and effectiveness |
| OxygenConcentrationControl Range | 20% O₂~60% O₂ | 21% O₂~65% O₂ | Similar-10.In general, theconcentration of oxygen inthe nature atmosphere isabout 20.9%. Comparedwith the predicate device,the oxygen concentrationcontrol range of YP-3000is included in the oxygenconcentration control range of the predicatedevice, the oxygenconcentration range isverified to meet the designrequirement, so thisdifference does not raisenew questions of safetyand effectiveness. |
| OxygenConcentrationControlPrecision | ±4% O₂ | ±5% O₂ | Similar-11.Based on the analysis ofthe oxygen concentrationcontrol range, this indexindicates the deviationrange between the actualoxygen concentration inthe incubator and thecontrol value duringoxygen concentrationcontrol. The oxygenconcentration precision isverified to meet the designrequirement and is slightlydifferent to predicatedevice. This differencedoes not raise newquestions of safety andeffectiveness. |
| Carbon dioxide(CO2)ConcentrationInside the HoodUnder IncubatorMode | <0.5% | 0.2% | Similar-12.Both the subject deviceand predicate deviceconform to IEC 60601-2-19 clause 201.12.4.2.101,so this difference does notraise new questions ofsafety and effectiveness. |
| Weight Scale | |||
| Function Range | 100mg to 8kg | 300mg to 8kg | Similar-13.Both the subject deviceand predicate devicecomply with therequirements of201.12.1.112 of IEC60601-2-19, and thedifference of this indicatordoes not affect thetemperature controlperformance of theproduct. It is an auxiliaryfunction, so this differencedoes not raise newquestions of safety andeffectiveness. |
| Accuracy | ± 10 mg | ± 10 mg | Same |
| Integrated X-Ray Cassette /Tray | Yes | Yes | Same |
| Drawer | Yes | Yes | Same |
| Bed-tiltMechanism | Yes | Yes | Same |
| Operating Noise | |||
| Operating NoiseVolume inPatientCompartment | ≤50dB (Under thesteady temperaturecondition) | <49dB | Similar-14.Both the subject deviceand predicate device meetthe requirements of clause201.9.6.2.1.101 ofIEC60601-2-19, so thisdifference does not raisenew questions of safetyand effectiveness. |
| Alarm Volume | According to IEC60601-2-19 and IEC60601-1-8 | According to IEC60601-2-19 and IEC60601-1-8 | Same |
| Alarms | |||
| Power FailureAlarm | Yes | Yes | Same |
| Non-recoverablesystem failure | Yes | Yes | Same |
| Failure of Fansystem | Fan Motor Alarm | Fan Failure Alarm | Same |
| High Air Temp | Display temperature is3°C higher than settemperature | 1.5°C over SET | Similar-15.Both the subject deviceand predicate device meetthe requirements of201.15.4.2.1 dd) of IEC60601-2-19, so thisdifference does not raisenew questions of safetyand effectiveness. |
| Low Air Temp | Display temperature is3°C lower than settemperature | 3.0°C under SET | Same |
| Baby Cold | Display temperatureof sensor 1 is 1°Clower than settemperature | 1.0°C under SET | Same |
| Baby Hot | Display temperatureof sensor 1 is 1°Chigher than settemperature | 1.0°C over SET | Same |
| Air Overheat | Temperature ofincubator is not over38°C (set value is lessthan 37°C), or not over39.5°C (set value isover than 37°C) | >38°C (SET≤37°C)>40°C (SET>37°C) | Similar-16.Both the subject deviceand predicate device meetthe requirements of201.15.4.2.1 aa) of IEC60601-2-19, so thisdifference does not raisenew questions of safetyand effectiveness. |
| Skin OverheatAlarm | The temperaturemeasured by skintemperature sensor | Not provided | Similar-17.Both the subject deviceand predicate device meet |
| under the warmermode is over 38.5°C | the requirements of201.15.4.2.1 bb) of IEC60601-2-19, so thisdifference does not raisenew questions of safetyand effectiveness. | ||
| Water Shortage | Water tank is lackingwater | Water tank is lackingwater | Same |
| Operating Condition Description | |||
| Temperature | +20~+30°C | +20~+30°C | Same |
| Humidity | 30%~75%RH | 10% to 95% RH | Similar-18.Under the specifiedworking conditions,whether the safety andeffectiveness of theproduct can be guaranteeddepends on the productitself and cannot beconcluded through datacomparison. Therefore, weprovide an environmentaltest report to prove that thesubject device YP-3000can work normally underthis operation condition, sothis difference does notraise new questions ofsafety and effectiveness. |
| Storage Condition Description | |||
| Temperature | -20~+55°C | -25~+60°C | Similar-19.Under the specifiedworking conditions,whether the safety andeffectiveness of theproduct can be guaranteeddepends on the productitself and cannot beconcluded through datacomparison.Environmental testingsupports that the subjectdevice YP-3000 performsas intended under thisoperation condition, so thisdifference does not raisenew questions of safetyand effectiveness. |
| Relativehumidity | ≤93%RH | ≤95%RH | Similar-20.Under the specifiedworking conditions,whether the safety andeffectiveness of theproduct can be guaranteeddepends on the productitself and cannot beconcluded through datacomparison. Therefore, weprovided environmentaltesting report to supportthat the subject device YP-3000 works normally underthis operation condition, sothis difference does notraise new questions ofsafety and effectiveness. |
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Discussion of Substantial Equivalence:
Comparison of Product performance, Power Supply, Operating Conditions, and Storage Conditions between the predicate device and the proposed device, YP-3000, identified minor differences with the Predicate Device OmniBed; the differences were supported with performance testing, as appropriate, and do not raise new questions of device safety and effectiveness. The proposed device YP-3000 has similar indications for use; the technological characteristics differences listed in the above table between
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the proposed device YP-3000 and the predicate device OmniBed do not raise any new questions of safety and effectiveness.
Non-Clinical Testing:
The following bench testing was conducted in order to support substantial equivalence:
- ES 60601-1:2006+A1:2012 Medical electrical equipment -- part 1: . general requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- IEC 6060-1-8 General requirements for basic safety and essential . performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- IEC 60601-2-19 Particular requirements for the basic safety and . essential performance of infant incubators.
- IEC 60601-2-21 Particular requirements for the basic safety and . essential performance of infant radiant warmers.
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: . Tests for in vitro cytotoxicity.
- . ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
- Guidance for Industry and FDA Staff, titled "Guidance for the Content . of Premarket Submissions for Software Contained in Medical Devices," issued on: May 11, 2005.
- Guidance for Industry and Food and Drug Administration Staff titled . "Applying Human Factors and Usability Engineering to Medical Devices," issued on: February 3, 2016.
- Guidance for Industry and Food and Drug Administration Staff ● titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," issued on March 17, 2015.
Clinical Testing:
Clinical evaluation is not applicable for the proposed device.
8. Conclusion [21 CFR 807.92(b)(3)]
Based on the performed testing per the standards above and comparison of technological characteristics with the predicate device, the YP-3000 Infant
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Incubator is substantially equivalent to the predicate device. It does not introduce a new intended use and has equivalent technological characteristics. The differences from the predicate do not introduce any new potential hazards or safety risks.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).